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Drug Development Testicular Toxicity Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance entitled Testicular Toxicity: Evaluation During Drug Development.

Draft Guide on Drug Supplier Verification Systems

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Verification Systems Under the Drug Supply Chain Security A...

FDA Gets New Opioid Fight Authorities

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FDA commissioner Scott Gottlieb says the agency gained new authorities under the SUPPORT bill to combat the nations opioid crisis....

CDRH Posts ASCA Information

[ Price : $8.95]

CDRH posts information about its planned Accreditation Scheme for Conformity Assessment pilot program to accredit testing laborato...

Revised Safety Alert on Alcons CyPass Micro-Stent

[ Price : $8.95]

FDA issues a revised safety alert on Alcons CyPass Micro-Stent due to its risk of eye damage.

Masimo RD SET for Pulse Oximetry Cleared

[ Price : $8.95]

FDA clears a Masimo 510(k) for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry that is ...

Priority Voucher Awarded to Leadiant Bioscience

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Federal Register notice: FDA awards a priority review voucher to Leadiant Bioscience after determining that rare disease drug Revc...

Economic Advisors Praise FDA on Drug Costs

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The Council on Economic Advisors says FDA efforts to control drug prices are providing savings to consumers.

Drug Supply Chain Verification System Guidance

[ Price : $8.95]

FDA publishes a draft guidance on legal requirements for drug supply chain verification systems.

FDA Approves Saxenda Label Update on CV Risk

[ Price : $8.95]

FDA approves an updated label for Novo Nordisks Saxenda to add cardiovascular risk data for the drugs active ingredient from the L...